Sterility Supervisor

Eurofins; Centennial (CO); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA Clinical Diagnostics is seeking a Laboratory Supervisor to lead a microbiology-focused department, ensuring GMP compliance and high-quality patient results. The role involves training staff, coordinating schedules, and driving process improvements to meet client expectations and company objectives.

The LS will review test results for accuracy, support QA investigations, and oversee data trending and reporting while maintaining regulatory adherence and staff competency under the

Qualifications

• 4 years of microbiology experience.
• Bachelor’s Degree in a relevant science field.
• Knowledge of CAP/CLIA and FDA regulations.
• Strong communication and leadership skills.
• Ability to interpret regulations and apply them.

Responsibilities

• Supervise the day-to-day operation of the department.
• Schedule staff to meet production schedules.
• Counsels staff regarding problems encountered in daily operations.
• Works with Quality Assurance to resolve client complaints by investigating problems, developing solutions and making recommendations to management.
• Identifies process improvements to better meet client expectations and company objectives.
• Oversees the monitoring of inventory/ordering by establishing par levels and restocking points for supplies and reagents.
• Performs timely generation of Phase I Out of Specification (OOS) Investigative Reports.
• Tracking and trending of department data.

Skills

Microbiology

Team leadership

Regulatory compliance

Communication skills

Problem solving

Education

Bachelor’s degree in a chemical, physical, biological science or clinical laboratory science

Job description

• Compensation: USD 65,000 - USD 85,000 - yearly

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

Job Description

The Laboratory Supervisor (LS) will work under the general direction and guidance of the Department Manager and Laboratory Operations Management. The LS will perform job duties in accordance with GMPs, policies and procedures, and testing requirements. The LS will be responsible for training/advising technologists and support staff and providing specialized expertise in assigned technical areas. The LS will handle laboratory proficiency testing/reporting and evaluate/recommend new testing procedures.

The incumbent will apply technical skills and knowledge as it relates to laboratory results and accreditation, handling technical support issues for the department. Also responsible for critical review of patient results and reporting.

• Supervise the day-to-day operation of the department to ensure smooth flow of samples and testing.
• Oversees the scheduling of staff to ensure production schedules are met.
• Counsels staff regarding problems encountered in daily operations.
• Works with Quality Assurance to resolve client complaints by investigating problems, developing solutions and making recommendations to management.
• Identifies process improvements to better meet client expectations and company objectives.
• Recommends new equipment for the department.
• Oversees the monitoring of inventory/ordering by establishing and maintaining par levels and restocking points for supplies and reagents.
• Performs duties in compliance with all applicable regulatory and accrediting agencies.
• Supports Eurofins DPT’s business philosophy, leadership values and ethics.
• Assures technologists are adequately trained. Provides training and technical advice to technologists and other support staff. Promotes uniformity in the implementation of policies and procedures.
• Performs technologist’s job duties as needed to support appropriate staffing levels.
• Assures that reviews of test results are timely and accurate and are involved with reporting patient results.
• Tracking and trending of department data.
• Analyzes Environmental Monitoring results for staff performance and feedback.
• Performs timely generation of Phase I Out of Specification (OOS) Investigative Reports.
• Perform Quality Indicator metric analysis, review and change implementation.
• Perform internal and external audit responsibilities as needed.
• Oversees the checking and transfer of data as necessary and takes steps to correct possibly inaccurate data prior to continued processing or release.

Qualifications

Essential Knowledge, Skills and Abilities

• 4 years of microbiology experience.
• Bachelor’s Degree in a chemical, physical, biological science or a clinical laboratory science/medical technology program by an accrediting institution.
• Knowledge of regulatory requirements in both the CAP/CLIA setting as well as knowledge of FDA, and industry standards.
• Must be able to interpret and apply government and industry regulations.
• Excellent and effective written and oral communication skills, including presentation skills and interpersonal skills.
• Exceptional cross-functional team leadership skills and ability to work in close collaboration with others.
• Strong organizational and planning skills as well as strong attention to detail.
• Ability to work independently with limited supervision, adapt to change and manage multiple tasks.
• Ability to analyze, define and effectively convey difficult and complex issues in a way that accurately communicates the issues to leadership.
• Ability to troubleshoot and make decisions on complex issues, often in a cross-functional team setting.
• Technical knowledge of applicable regulations.
• Effecting operations of a clinical reference laboratory.
• Analytical thinking and communication skills.

Physical Requirements

• Physical dexterity sufficient to use hands, arms, and shoulders repetitively to operate a keyboard and other office equipment, use a telephone, access file cabinets and other items stored at various levels, including overhead.
• Ability to speak and hear well enough to communicate clearly and understandably with sufficient volume to ensure an accurate exchange of information at a normal conversational distance, over the telephone, and in a group setting.
• Ability to continuously operate a personal computer for extended periods of time (4 or more hours).
• Mental acuity sufficient to collect and interpret data, evaluate, reason, define problems, establish facts, draw valid conclusions, make valid judgments and decisions.

The essential physical and mental requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• This laboratory carefully maintains all hazardous materials. All employees must abide by Eurofins DPT’s Safety and Exposure procedures. This includes using the provided safety clothing and equipment.
• For a list of potential chemical hazards, see appropriate SDS sheet.

Job descriptions are not intended, and should not be construed, to be exhaustive lists of all responsibilities, skills, efforts or working conditions associated with a job. They are meant to be accurate reflections of the principal job elements essential for making fair pay decisions. Employees may perform other related duties as negotiated to meet the ongoing needs of the organization.

Additional Information

Compensation:

Schedule:

• 2nd shiftSun-Wed

What we offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.